Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 361 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infection risk due to sterile barrier failure) where the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 361 units of G-PIN 2.8BL 3.2PL 60CM 2PK trauma guide wires (catalog number 467265). These devices are intended to be used as guide pins for the insertion of implants, such as cannulated screws and intramedullary nails, and for drilling bone.
The recall is being conducted because of insufficient packaging design verification and an occurrence rate of complaints for sterile barrier failure that exceeds expected levels. Guide wires packaged in the affected configuration have the potential for sterile barrier breach, which leads to a possible risk for infection.
The affected products were distributed worldwide, including nationwide in the United States and in Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and the Netherlands. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 361
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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